CLINICAL OUTCOME STUDIES OF ANTIANGINAL DRUG-THERAPY FOR PATIENTS WITH STABLE CORONARY-DISEASE - AN INDICATION FOR CLINICAL-TRIALS

Despite recent advances in prevention and treatment, the number of ind ividuals who suffer from chronic symptomatic coronary artery disease i s rising. Past experience with clinical trials in cardiovascular disea se has shown that the results are often unanticipated and at odds with the scientific rationale that existed beforehand. Also, important les sons have been learned concerning sample size and the choice of end-po ints. One of these has been the unreliability of surrogates (such as b lood pressure, exercise capacity and number of anginal attacks) in pre dicting the effect of treatment on morbidity and mortality. The curren t drug therapy for stable angina in patients without a history of myoc ardial infarction has not been tested in large-scale clinical trials. No data exist for organic nitrates. The rationale for using beta-block ers comes from trials in patients who had a history of myocardial infa rction. Recent experience with sustained release calcium channel antag onists suggests that they appear to be safe in patients with stable an gina. Their effect on overall clinical outcome remains to be establish ed, however. It is for this reason that trials such as ACTION are both justifiable and needed.